BACKGROUND

The macrolides are among the most effective antibiotics against infections due to Chlamydia and Mycoplasma. The drug in such cases must have marked antibacterial activity, good oral bioavailability, and high intracellular diffusion--indispensable for instance with Chlamydia infection. Rokitamycin, a macrolide with a 16-atom lactone ring, has the features for use in the treatment of genital infections caused by Chlamydia or Mycoplasma, penetrating the cell and reaching considerably higher concentrations than other drugs of the same class. The aim of this trial was to gain further knowledge of rokitamycin in genital infections, including cases infected with Mycoplasma hominis, comparing the efficacy and safety of this drug with josamycin, another macrolide widely employed in clinical practice.

METHODS

Patients of either sex, over the age of 18 years, with infections due to Chlamydia trachomatis and Mycoplasma hominis, were admitted. The trial was conducted in accordance with the Declaration of Helsinki and amendments. Fifteen patients were given rokitamycin, one 400 mg tablet every 12 h, and another fifteen received josamycin, one 500 mg tablet every 8 h, for 14 days. Before starting treatment, after the 14 days and after 42 days' follow-up the severity of the following symptoms was assessed: pruritus, burning, erythema, pollakiuria, dysuria, using a four-point rating scale (0 = absent, 1 = mild, 2 = moderate, 3 = strong). The presence or absence of leukorrhea was noted. Patients entered the severity of subjective symptoms daily in a diary. At the end of the trial overall assessments were made on the clinical response, microbiological outcome and efficacy.

RESULTS

Thirty patients of both sexes were admitted, age 21-43 years, with genital infections due to Chlamydia trachomatis and/or Mycoplasma hominis. Fifteen were given rokitamycin, 800 mg/day, and 15 josamycin, 1500 mg/day, for 14 days. In 13 cases in each group an antibiotic was prescribed for the partner too. At the start of the trial microbiological samples were taken; in 13 cases a urethral swab was taken (six in the josamycin and seven in the rokitamycin group), and 17 cervical swabs were taken (respectively nine and eight). At the end of the trial 93% of patients gave a negative microbiological result. Mycoplasma hominis was isolated from one patient treated with rokitamycin, and Chlamydia trachomatis from one patient given josamycin. Symptoms improved at a similar rate in both groups, with no significant differences between the drugs. Safety was excellent in both groups, with no complaints of adverse reactions.

CONCLUSIONS

This trial demonstrates the excellent activity of macrolide antibiotics against genital infections due to Mycoplasma hominis and Chlamydia trachomatis. Rokitamycin and josamycin both gave good or excellent clinical and microbiological outcomes in more than 90% of the cases. Both were extremely well tolerated. These findings confirm and extend the indications for rokitamycin, found in earlier trials to be extremely effective in the treatment of urethritis due to Chlamydia trachomatis and--as a whole--in infections caused by this microrganism.